The Central Drugs Research Institute (CDRI) has developed a candidate drug to treat osteoporosis and is holding negotiations with some private partners to launch the phase I clinical trials. Negotiations are in progress towards licensing of compound S007-1500 (rapid fracture healing agent) for further collaborative development.

A novel anti-leukaemic compound (s007-1235) has been discovered and it has shown better activity than the Imatinib and Dasatinib in the initial studies. Significant progress has been made in the further development of other candidate drugs and new leads in the areas of malaria, osteoporosis, thrombosis and diabetes, the report said.

The premier institute has already licensed a promising new lead molecule (CDR 914K058 – osteogenic) to Kemxtree of USA last year for developing it as a rapid fracture healing oral drug. As many as six candidate drugs are under advanced stage of development and four of them were already licensed to private companies.

Phase-I clinical pharmacokinetic studies have been completed in 16 healthy male volunteers at PGIMER, Chandigarh in collaboration with IPCA Labs, Mumbai for an anti-malarial drug. Samples analysed and report sent to IPCA which holds the license. Likewise, pre-clinical data was under compilation for IND submission for another anti-malarial drug, also licensed to IPCA.

It has also developed an anti-hyperglycemic candidate drug (CDR134D123) and licensed the same to TVC Sky Shop, Mumbai. “Detailed quality monograph on the epicarp of the plant Xylocarpus granatum as per the specifications has been submitted. The matter is awaiting clearance for inclusion in the Extra Ayurvedic Pharmacopoeia,” the report said.

The institute is also holding talks with interested GMP-certified companies about another anti-hyperglycemic candidate drug. The preparations for the drug formulation to be used in phase-I single dose and multiple dose clinical trials are in progress and clinical trials would commence soon.